ORIGINAL ARTICLE Role of homoeopathic medicines in treating uterine fibroid: a prospective observational study

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1 ORIGINAL ARTICLE a prospective observational study Iqbal Jahan Quadri, MD Shahid Ali, B Vatsalya, Hima Bindu Ponnam and Nikhat Parveen S Background & objective: Uterine fibroids (UF) or leiomyomas are found in 25% to 35% women of reproductive age. It is one of the most common indications for hysterectomy further leading to complications. The present observational study on UF was undertaken to arrive at a group of useful homoeopathic medicines for the treatment of the same. Methods: A prospective observational study was conducted at Princess Durru Shehvar Children s and General Hospital, Hyderabad in coordination with its Extension Unit of Drug Standardization Unit (Hyderabad) of Central Council for Research in Homoeopathy during September August One hundred and thirty eight patients with UF were screened as per the pre-set criteria and 103 patients were enrolled. Homoeopathic Medicines were prescribed to the enrolled patients on the basis of repertorization of the symptom totality. The improvement of the patients was assessed subjectively through the clinical symptoms and objectively through USG pelvis. Results: Out of 103 patients enrolled, follow up of 71 patients was completed as per protocol and their data was analyzed. In 12 patients, fibroids resolved completely. There was statistically significant reduction in some of the symptoms/signs as well as in size of fibroid(s) (p= <0.05). Calcarea carbonica (n=16), Pulsatilla (n=14), Phosphorus (n=7), Lycopodium (n=5), Sulphur (n=3) and Kali carbonica (n=2) were found to be most useful among the prescribed homoeopathic medicines. Limitations: This was an observational study with no control arm, with the duration of follow up being only 8 months. Conclusion: This study has shown positive results in terms of reduction and resolution of UFs with homoeopathic treatment. Further RCTs with long follow ups need be conducted for definite conclusions. Keywords: Homoeopathy; USG Pelvis ; Uterine leiomyoma INTRODUCTION Uterine Leiomyomas/fibroids (UF) are benign smooth muscle tumors that represent one of the most common gynaecological problems in women of reproductive age. They are the primary indication for nearly 600,000 hysterectomies performed each year in the United States, and for 37,000 myomectomies performed annually. In a comprehensive review of patients in United States conducted by Schwartz, incidence rates varied from 2.0 to 12.8 per 1000 women per year. 1 Presently people with uterine fibroids undergo total abdominal, vaginal or laparoscopic assisted hysterectomies around the world. In less developed Address for Correspondence: Dr. Iqbal Jahan Quadari, HOD, Department of Gynaecology, Princess Durru Shehvar Children s & General Hospital, Purani Haveli, Hyderabad E.mail:- extncruhyd@yahoo.com/extncruhyd@gmail.com 8 and more populous countries like India, the numbers may be even higher. 2 However, the exact incidence of UF in reproductive age women is difficult to ascertain for several reasons. Primarily, the majority of fibroids are asymptomatic, resulting in low clinical detection rates. 3,4 Risk factors primarily include a) age with increasing incidence as women approach perimenopause and b) African- American race. The other risk factors are c) positive family history (having a family member with fibroid increases the risk by 3 times), d) obesity (there is 2.3 times increased risk in women with BMI > 25.4 kg/m 2 ) etc. Symptoms differ widely but may include menorrhagia, pelvic pain & pressure, infertility and pregnancy related complications. Diagnosis can be made with the help of radiographs, trans-abdominal & trans-vaginal ultrasound, MRI and Hysteroscopy. As this is becoming the common reason for hysterectomies these days, there is an increasing need for non invasive

2 alternatives for uterine fibroids. 5 A study by Popov shows that Homoeopathy can stop the growth of the tumor, reducing size (26.8%) as well as to control pain (78.9%) and abnormal endometrial bleeding (75%). He also highlights that certain patterns of response to treatment were found i.e. in certain patients positive response was observed at the beginning of the treatment, but subsequently ceased. Secondly in few patients menorrhagia improved but the growth of the tumor was observed. The various medicines which were used are Nux vomica, Sulphur, Lycopodium, Calcium iodatum, Apis mellifica, Cimicifuga, Calcarea carbonica, Silicea, Ignatia, China officinalis, Argentum nitricum, Sabina, Iodatum, Sepia, Calcarea fluoricum, and Pulsatilla. 6 A single case record by Iqbal Jahan et al has also highlighted the resolution of fibroid with Lycopodium. 7 Thus an Extra Mural Project was taken up by the Princess Durru Shehvar Children s and General Hospital, Hyderabad in coordination with its Extension Unit of Drug Standardization Unit (Hyderabad) of Central Council for Research in Homoeopathy to identify the potential role of homoeopathic medicines and to ascertain if homoeopathy can offer an alternative for the treatment of UF. MATERIAL AND METHODS Study Design and setting This was conducted at Princess Durru Shehvar Children s and General Hospital, Hyderabad in coordination with Extension Unit of Drug Standardization Unit (Hyderabad) under Central Council for Research in Homoeopathy during the period September 2006 to August The protocol was approved from the Ethical Committee of the study site. Informed consent was taken from all the patients who were willing to participate in the study. Patient selection For patient selection, the ICD 10 Criteria as following was considered: Benign neoplasms of uterus with morphology code /0 Fibromyoma of uterus D25.1 submucous leiomyoma of uterus D25.0 intramural leiomyoma of uterus D25.2 subserosal leiomyoma of uterus D25.9 leiomyoma of uterus, unspecified Out of these groups, females in the childbearing age group i.e., 30 to 40 yrs of age diagnosed with subserosal & intramural fibroid on ultrasonography were included in the study. Asymptomatic patients presenting with UF growing in size were also included. Woman with heavy, prolonged menstrual periods and unusual monthly bleeding which can lead to hypovolemia & severe anaemia (Haemoglobin < 6mg%); pregnancy; non- symptomatic fibroids in the females of menopausal age; woman diagnosed on scan having sub mucosal fibroids were excluded. Figure 1: Flow of patients in the study Initial screening (as per inclusion criteria) (n = 138) EXCLudEd (n = 35) Women of Menopausal age n = 3 Women with submucous fibroid n = 32 Enrolled (n = 103) drop out cases (n = 32) Cases not reported to follow ups as per protocol ( n = 32) data available for analysis as per protocol Regular follow up (n = 71) 9

3 Treatment and follow up Homoeopathic treatment was given as per instructions given in Hahnemann s Organon of Medicine. 8 Its characteristics are: Selection of one drug at a time, using the similia principle and the drug picture and disease picture should be as similar as possible. Homoeopathic Medicines were prescribed to the enrolled patients by repertorising the symptom totality. The repertorisation was done using the Complete Repertory from the software of Hompath Classic. 9 The final selection of the medicine was done after confirming with the Materia Medica. 10,11,12 Selected medicine was given in 30c potency in single dose. After a particular prescription, if the improvement remained stand still, 200c potency was given and later as per requirement. Placebo pills were given as soon as the improvement was observed. Investigators were allowed to change the prescription if the first prescription didn t work as per the follow up symptom totality by reanalyzing the case. Outcome measures The patients were assessed at 7 days, 15 days, 1 month, 4 months and 8 months for clinical symptoms. Periodical ultrasonographic scans were conducted over 8 months. The final assessment was done as shown in Table 1. Fibroid size and number were assessed by vaginal and/or abdominal ultrasonogram at and 8 months. UF sizes is evaluated, measuring the three main diameters (D1,D2,D3) and applying the formula of the ellipsoid (D1*D2*D3*0.52). An arithmetic mean of the sizes was used in presence of two fibroids. 13 However in this study as two diameters were only measured, the highest diameter amongst the two diameters was considered as third diameter for calculating the volume. Table 1 : Parameters adapted for assessment of response to treatment 1. Improvement: Marked More than 75% improvement in the size of fibroid(s) with clinical improvement as compared to Moderate Mild 10 50% to less than 75% improvement in the size of fibroid(s) with clinical improvement as compared to 25% to less than 50% improvement in the size of fibroid(s) with clinical improvement as compared to 2. No significant change Less than 25% improvement in the size of fibroid(s) with clinical improvement as compared to 3. Not improved No change in the size of fibroid(s) as compared to 4. Worsened Increase in the size of fibroid(s) as compared to 5. Static No change of the size of fibroid(s) with clinical improvement after sufficient trial of best indicated medicines have been tried Statistical analysis The result analysis was done by using SPSS (Statistical package for social science) Version 16 & System Stats Version 10 on the clinical parameters and on the size of uterine fibroids before and after 8 months of treatment (t test, McNemmar test) as per nature of data. Results One hundred and thirty eight patients with UF were screened and 35 patients were excluded. Among 103 patients enrolled, 32 patients were not analyzed as they deviated from the protocol norms. The analysis reflects the data of 71 patients who were analyzed as per protocol. The flow of the patients in the study is given in Figure 1. Baseline details of the patients are given in Table 2. McNemar test showed significant changes in proportion of patients with symptoms/signs such as disturbances in menstrual cycle, pain during menses due to UF in patients (Table 3a). The reduction in number and size of the uterine fibroids after 8 months of treatment as assessed ultrasonographically was also found to be significant statistically in patients irrespective of single or with multiple (2-4) fibroids (Table 3b). An overall assessment of study patients

4 Table 2 : Baseline data of 71 patients analyzed in the study Variable No. of patients(%) Variable No. of patients(%) 1. Age group in years (32.4) (67.6) 2. Body Mass Index (BMI) < (2.8) (29.6) (47.9) (19.7) 3. Marital Status Unmarried 2(2.8) Married 59(83.1) Widow 7(9.9) Divorced 3(4.2) 4. Parity (Children) Nullipara 14(19.7) (50.7) (23.9) 7-9 4(5.6) 5. Family History of Uterine Fibroid(s) Present 19(26.8) Absent 52(73.2) 6. Use of Oral contraceptive pills (OCP) Used 15(21.1) Not used 56(78.9) 7. Menarchal Age 10-12yrs 29(40.8) 13-15yrs 36(50.7) 16-18yrs 6(8.5) 8. Number of fibroids Single 51(71.83) Multiple 20(28.17) 9. Type of fibroid Intramural 54(76.1) Subserosal 9(12.7) Both 8(11.3) 10. Clinical presentation Absent 8(11.3) Present 63(88.7) 10.a) Disturbances in menstrual cycle Absent 13(18.3) Present 58(81.7) 10.b) Menstrual pain Absent 39(54.9) Present 32(45.1) 10.c) Pressure symptoms Absent 67(94.4) Present 4(5.6) 10. d) Infertility Absent 57(80.3) Present 14(19.7) Table 3 (a) : Clinical outcome parameters of studied patients Number and type of Fibroid At entry % At end % P value Clinical presentation Absent * Present Disturbances in menstrual cycle Absent ** Present Menstrual pain Absent ** Present Pressure symptoms Absent * Present McNemar Test (significant at p<0.05**, not significant p>0.05*) based on both clinical and ultrasonographic parameters is given in Table 3c. It is observed that 9 medicines were used frequently for prescribing to the patients of UF (Table 4) Calcarea carbonica (n=16, 22.5%), Pulsatilla (n=14,19.7%), Thuja (n=11,15.5%), Natrum muriaticum (n=7,9.9%), Phosphorus (n=7,9.9%) and Sepia (n=6,8.5%). Among the medicines less used in this study are Lycopodium (n=5,7.0%), Sulphur (n=3, 4.2%) and Kali carbonica (n=2,2.8%). 11

5 Table 3 (b) : Statistical evaluation of size of uterine fibroids Size of fibroid Mean(SD) Mean diff(95% CI) P-value in cm 3 At entry At end Single fibroid 43.82(74.38) 24.22(65.72) 19.59(10.07 to 29.11) 0.001** (n= 51) Multiple fibroids 17.20(25.26) 10.66(20.19) 6.53(2.15 to 10.91) 0.006** (n= 20) Paired t test (significant at p<0.05**, not significant p>0.05*) Table 3 (c) : Outcome assessment of studied patients Improvement status Single fibroid Multiple fibroid Total (n=51) (n=21) No of patients (%) Marked 24(47.1) 5(25) 29(41) Moderate 8(15.7) 4(20) 12(17) Mild 14(27.5) 3(15) 17(24) Not significant 2(3.9) 6(30) 8(11) Worse 3(5.9) 2(10) 5(7) Figure 2 : Symptom-wise improvement status of patients 12

6 Table 4: Improvement status with homoeopathic medicines used Medicine No. of Improvement assessment prescribed cases % Marked Moderate Mild No improve- improve- improve- Signiment ment ment ficant Calcarea carbonica Kali carbonica Lycopodium Natrum muriaticum Phosphorus Pulsatilla Sepia Sulphur Thuja Total % of UF patients (n=58) showed various levels of improvement at various stages of their treatment during the study period of eight months (Figure 2); 29 patients showed marked improvement where in 12 patients fibroid has been completely resolved, 12 patients showed moderate improvement, 17 patients showed mild improvement, 8 patients showed no significant improvement respectively whereas in 5 patients it got worsened. Discussion This was conducted in India for treating patients of UF with homeopathic medicines and it reflected the positive results of homoeopathic therapy in these patients. Patients diagnosed with uterine fibroid of variable duration were enrolled. The incidence found to be more in 35-40yrs of age. The studies conducted by Marshall et al 14 demonstrated an increased incidence rates of fibroid as women approach the perimenopause and the same is corroborated in this study. When risk factors are compared, majority cases showed Body Mass Index > 25. This has been investigated as an independent risk factor for fibroid growth in epidemiological studies. 14 Faerstein et al 15 demonstrated a 2.3 fold increase of risk in women with BMI > 25.4 Kg/m 2. The same is corroborated in this study. Family history of fibroids is being reported first by Winkler and Hoffman 16, who demonstrated a 4.2 fold increase in fibroids among first degree relatives. In this study 26.8% patients have family history of UF. Abnormal uterine bleeding is the most frequently cited symptom in women with fibroids as per Stewart s classification system 17 of clinical presentation of fibroid and in the present study 30 cases reported with profuse bleeding per vagina as the chief complaint. In this study, clinical presentation improved in 76.2% patients. Of the 58 patients presenting with disturbances in menstrual cycles such as bleeding, short cycle duration and irregular cycles, 54 patients improved and only 4 patients, some disturbances in the cycles persisted after 8 months of treatment. Dysmenorrhoea improved in all the cases, who had initially presented with this complaint, except in one case. The medicines found useful in this observational study were Calcarea carb., Pulsatilla, Phosphorus, Lycopodium, Sulphur and Kali carb. As rightly said by Thomas Skinner 18 Constitutional treatment alone was and is all that is necessary for successful treatment of all vaginal, uterine and ovarian diseases. The same holds true in this study as the medicines prescribed are wholly on the symptom totality and the constitutional basis on repertorization and final decision with the consultation of Materia Medica. The strength of this study is that it represents a pragmatic setting of homoeopathic practice which reflects the day-to-day clinical practice. To validate the efficacy of Homoeopathy in the treatment of UF, Randomized Control Trials (RCT) are needed. To assess the improvement of the cases more authentically colour doppler ultrasonography evaluating volume, 13

7 echogenecity and vascularity of the fibroids can be considered. Also further studies can be conducted to verify the action of homoeopathic medicines in fibroid size reduction to basically evaluate the reason whether the reduction is due to the diminution in the blood supply or due to the degenerative changes resulted. Conclusion This study has shown positive results in terms of reduction and resolution of UFs with homoeopathic treatment. Further RCTs with long follow ups need to be conducted for definite conclusions. Conflict of Interest We declare no conflict of interest. Acknowledgement This study was conducted under the Extra-Mural Research Scheme of Department of AYUSH, Ministry of Health and Family Welfare, Government of India. The authors acknowledge the financial grant and support received from the Department of AYUSH, Ministry of Health and Family Welfare, Government of India. The authors wish to express their whole hearted gratitude to Dr. C. Nayak, Director General, CCRH, Dr. Anil Khurana, Assistant Director (H), CCRH and Dr. Divya Taneja, Research Officer (H), CCRH for their inspiration, and guidance during the study. The authors also thank Dr. Varanasi Roja, Research Officer (H) and Mrs. Maya, Statistical Assistant, CCRH for conducting the statistical analysis of the study. The authors also thank Dr. Radha Kishan Rao, Director, Dr. Shabnam Raza, MD, DGO, all the doctors and staff of Princess Durru Shehvar Children s & General Hospital, Hyderabad for their kind co-operation throughout the study. Also thanks to Ms. Faiqunnisa, Office Assistant for her co-operation in all the data setting of the project. Last but not the least thanks to all the patients enrolled in the study for their consent and co-operation. REFERENCES 1. Schwartz SM: Epidemiology of uterine leiomyomata. Clinical Onstetrics & Gynaecology 2001; 44: The American College of Obstetricians & Gynaecologists. Practice Bulletin Number 96, August Buttram VC, Reiter RC: Uterine leiomyomata:etiology, symptomatology and management. Fertil Steril 1981; 36: Lumsden MA, Wallace EM: Clinical presentation of uterine fibroids. Baillieres Clin Obstet Gynaecol 1998; 12: Rahi Victory, Walter Romano, John Benett, Michael P Diamond: Uterine leiomyomas; Clinical Gynaecology; Published by Churchill Livingstone Elsevier, Philadelphia 2006: Popov A V. Homoeopathy in treatment of patients with fibromyoma of the uterus; British Homeopathic Journal; 1992; 81: Iqbal J Q., Shahid Ali Md., Nikhat Parveen S., Vatsalya B. A Case of Uterine Fibroid, Indian Journal of Research in Homoeopathy; Vol. 2, No. 2, April-June 2008; Hahnemann Samuel. Organon of Medicine; 5 th & 6 th edition; New Delhi; B Jain Publishers; Jawahar Shah. Hompath Classic Ver 8.0. Complete Repertory. 10. Boericke W. New Manual of Homoeopathic Materia Medica & Repertory. B.Jain Publishers (P) Ltd, New Delhi Kent JT. Lectures on Homoeopathic Materia Medica. B.Jain Publishers (P) Ltd, New Delhi Allen H C: Genitalia Female, H.C.Allen s Therapeutic Notes, Dipanwita Publishers, Calcutta 1994; Palomba S, Orio F, Jr., Morelli M, Russo T, Pellicano M, Zupi E, et al. Raloxifene Administration in Premenopausal Women with Uterine Leiomyomas: A Pilot Study. The Journal of Clinical Endocrinology & Metabolism 87(8): Marshall LM, Speigelman D, Barbieri R, et al. Variation in the incidence of Uterine Leiomyoma among premenopausal women by age and race. Obstet Gynaecol 1997;90:

Subject Outline. Introduction to Homeopathic Method. Bachelor of Health Science (Homeopathy)

Subject Outline. Introduction to Homeopathic Method. Bachelor of Health Science (Homeopathy) Subject Outline Subject Name: Introduction to Homeopathic Method Subject Code: HOMC122 Award(s): Bachelor of Health Science (Homeopathy) Core/ Elective: Pre/corequisites: Student Workload: Delivery Mode: